International Clinical Trial Coordination and Legal Management
In the modern pharmaceutical world, clinical trials are often global in nature, spanning multiple countries (multi-center trials). Georgia, as part of this global chain, is attractive to international sponsors, but managing cross-border trials involves complex legal challenges. International trial coordination involves not only obtaining local permits but also harmonizing Georgian legislation with international contracts, global data protection standards (GDPR), and logistical regulations. This service is vital for global pharmaceutical companies and Contract Research Organizations (CROs) operating in Georgia.
Legal.ge offers legal services for international trial coordination. Our lawyers provide a legal bridge between the global protocol and local reality. We assist clients in managing risks related to border crossing, data transfer, and international agreements.
What Does International Trial Coordination Service Cover?
This service focuses on cross-border and complex legal issues:
- Contract Localization: Adapting global Clinical Trial Agreement (CTA) forms to Georgian legislation to ensure enforceability in Georgian courts.
- Import/Export Legal Support: Obtaining permits for the cross-border movement of Investigational Medicinal Products (IMP), laboratory kits, and biological samples (blood, tissue).
- Cross-Border Data Transfer: Legalizing the transfer of patient personal data abroad (to sponsor servers) in compliance with the Georgian Law on Personal Data Protection.
- Insurance Harmonization: Reviewing international insurance policies and, if necessary, adding local insurance to ensure full protection for Georgian patients.
- Foreign Staff Legalization: Resolving work authorization issues for international auditors and monitors in Georgia.
- Reporting to International Standards: Coordinating local safety reporting (SAE reporting) with global safety databases.
Common Situations and Scenarios
A frequent problem is the export of biological samples. Blood samples taken during the trial are often sent to a central laboratory abroad. If customs documentation and export permits are incorrectly processed, samples can be delayed at the border and spoil, damaging trial data. A lawyer resolves permitting issues with Customs and the Ministry of Health in advance.
Another scenario is Data Protection (GDPR). A European sponsor requires full GDPR compliance, while Georgia operates under local law. The lawyer prepares the consent form and data processing agreement to satisfy both European and Georgian requirements.
Georgian Legislation and Legal Framework
International coordination relies on the Customs Code of Georgia (sample transport), the Law on Personal Data Protection (data transfer), and the Law on Medicines and Pharmaceutical Activities. It is crucial that all procedures comply with ICH-GCP international standards, which are recognized by Georgian legislation.
Process of Receiving Services
A Legal.ge lawyer joins the project at the planning stage. A legal analysis of the logistical chain and data flow is conducted. The lawyer prepares all necessary contracts (bilingual) and obtains permits from the Agency. During the trial, they are in constant contact with the sponsor's global legal team to ensure timely reflection of local regulatory changes in processes. After the trial concludes, the lawyer ensures document archiving in compliance with legal requirements.
With our help, Georgia becomes a reliable and safe partner in global clinical trials.
Why Choose a Specialist on Legal.ge?
Managing international trials requires knowledge not only of Georgian law but also of international regulations (FDA, EMA) and English legal terminology. Legal.ge connects you with professionals experienced in working with multinational corporations who understand global Compliance standards.
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